Foreword |
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xiii | |
Preface |
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xv | |
About the author |
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xxvii | |
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1 What is the importance of quality to small businesses? |
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1 | (24) |
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1 | (1) |
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1.2 The importance of quality |
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2 | (1) |
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1.3 Quality -- the fundamentals |
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3 | (2) |
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5 | (1) |
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6 | (1) |
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7 | (6) |
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1.6.1 The significance of specifications |
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8 | (1) |
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1.6.2 Types of specification |
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8 | (2) |
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1.6.3 Supplier's responsibilities |
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10 | (1) |
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1.6.4 Purchaser's responsibilities |
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11 | (2) |
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1.7 Quality Assurance during a product's life cycle |
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13 | (6) |
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14 | (2) |
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16 | (1) |
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16 | (1) |
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17 | (2) |
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1.8 Benefits and costs of Quality Assurance |
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19 | (2) |
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1.9 Costs of quality failure |
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21 | (1) |
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21 | (1) |
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22 | (1) |
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1.10 What are the costs involved in an organisation obtaining registration to this standard? |
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22 | (3) |
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2 What is the background to ISO 9000? |
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25 | (70) |
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25 | (2) |
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2.2 What national and international standards are available (and what is their interoperability)? |
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27 | (5) |
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2.3 What about the growth of quality-specific standards? |
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32 | (2) |
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34 | (1) |
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2.5 What is the background to ISO 9000 and its current status? |
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35 | (8) |
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36 | (1) |
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36 | (2) |
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38 | (3) |
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41 | (1) |
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41 | (2) |
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43 | (2) |
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45 | (2) |
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2.8 What will ISO's core cases be in the future? |
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47 | (1) |
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2.9 What is the new structure of Annex SL? |
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47 | (4) |
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2.10 What is the current status of Annex SL revisions? |
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51 | (1) |
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2.11 What are the current ISO 9000 standards? |
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52 | (3) |
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2.11.1 ISO 9000:2015 Quality Management Systems -fundamentals and vocabulary |
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53 | (1) |
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2.11.2 ISO 9004:2009 Managing for the sustained success of an organisation: a Quality Management approach |
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53 | (1) |
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2.11.3 ISO 9001:2015 Quality Management Systems -requirements |
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54 | (1) |
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2.12 Quality Management Principles |
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55 | (4) |
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2.13 Impact of the changes |
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59 | (1) |
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2.14 ISO 9001:2015's compatibility with other management systems |
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60 | (3) |
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2.14.1 The OHSAS 18000 Series |
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61 | (1) |
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2.14.2 The ISO 14000 Series |
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62 | (1) |
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2.14.3 What is the difference between ISO 9000 and ISO 14000? |
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63 | (1) |
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2.15 What other standards are based on ISO 9001:2015? |
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63 | (8) |
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66 | (1) |
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2.15.2 Auditing management systems |
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66 | (1) |
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2.15.3 Automotive industry |
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66 | (1) |
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66 | (1) |
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66 | (1) |
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67 | (1) |
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67 | (1) |
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2.15.8 Electoral organisations |
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67 | (1) |
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2.15.9 Energy management systems |
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67 | (1) |
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2.15.10 Explosive atmospheres |
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67 | (1) |
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67 | (1) |
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2.15.12 Good manufacturing practice |
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68 | (1) |
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68 | (1) |
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68 | (1) |
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2.15.15 Information security |
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68 | (1) |
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2.15.16 Information technology |
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68 | (1) |
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68 | (1) |
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2.15.18 Measurement manufacturing systems |
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69 | (1) |
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69 | (1) |
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2.15.20 Multilayer piping systems |
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69 | (1) |
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2.15.21 Packaging -- transport packages (or dangerous products |
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69 | (1) |
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2.15.22 Petroleum, petrochemical and natural gas industries |
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69 | (1) |
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2.15.23 Quality Management System consultants |
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70 | (1) |
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2.15.24 Quality Management Systems projects |
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70 | (1) |
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70 | (1) |
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2.15.26 Ships and marine technology |
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70 | (1) |
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2.15.27 Software engineering |
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70 | (1) |
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70 | (1) |
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2.15.29 Supply chain management |
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71 | (1) |
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2.15.30 Systems engineering |
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71 | (1) |
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2.15.31 Telecommunications industry |
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71 | (1) |
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2.15.32 Testing and calibration laboratories |
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71 | (1) |
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2.15.33 Welding consumables |
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71 | (1) |
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2.16 What is ISO 9001:2015's basic process? |
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71 | (3) |
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2.17 What is the new structure of ISO 9001:2015? |
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74 | (10) |
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2.18 What about auditing ISO 9001:2015? |
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84 | (3) |
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2.18.1 Purpose of an audit |
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84 | (1) |
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85 | (1) |
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85 | (1) |
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86 | (1) |
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87 | (2) |
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2.19.1 Who can certify an organisation? |
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87 | (1) |
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2.19.2 What is required for certification? |
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88 | (1) |
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2.19.3 What is the difference between being certified and being registered? |
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88 | (1) |
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2.19.4 What is the difference between being certified and being compliant? |
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88 | (1) |
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2.19.5 What is the difference between being certified and being accredited? |
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89 | (1) |
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2.20 Who will be responsible for quality within an organisation? |
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89 | (1) |
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2.21 What is the future evolution of ISO 9000? |
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90 | (5) |
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Annex A Comparison between the ISO 9001:2015 and ISO 14001:2015 standards |
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91 | (4) |
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95 | (20) |
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95 | (4) |
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3.1.1 Example of a simple process flow chart |
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98 | (1) |
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3.2 But what is the process approach? |
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99 | (4) |
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3.3 Planning an organisation's business processes |
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103 | (4) |
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3.3.1 Core business process |
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105 | (2) |
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3.4 What kind of core processes would a business require? |
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107 | (4) |
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3.4.1 Supporting processes |
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108 | (2) |
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3.4.2 Primary supporting processes |
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110 | (1) |
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3.4.3 Secondary supporting processes |
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111 | (1) |
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3.5 Inter-relationship of process documentation |
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111 | (3) |
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3.6 The hierarchy of processes |
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114 | (1) |
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4 What is a Quality Management System? |
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115 | (24) |
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4.1 Quality Management System -- requirements |
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115 | (2) |
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4.1.1 Basic requirements of a Quality Management System |
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115 | (2) |
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4.2 Quality Management System -- principles |
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117 | (4) |
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4.3 Quality Management System -- approach |
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121 | (1) |
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4.4 Quality Management System -- structure |
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122 | (2) |
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122 | (2) |
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124 | (1) |
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4.5.7 Corporate policy statement |
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125 | (1) |
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125 | (1) |
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126 | (1) |
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4.7.1 What documented procedures are required by ISO 9001:2015? |
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127 | (1) |
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127 | (1) |
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4.8.7 What is the difference between a work instruction and a record? |
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128 | (1) |
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128 | (7) |
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4.9.7 Management responsibility |
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131 | (1) |
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131 | (1) |
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131 | (1) |
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4.9.4 Document and data control |
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132 | (1) |
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133 | (1) |
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4.9.6 Customer supplied products and services |
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133 | (1) |
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4.9.7 Identification and traceability |
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133 | (1) |
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133 | (1) |
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4.9.9 Inspection and testing |
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134 | (1) |
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4.9.10 Inspection, measuring and test equipment |
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134 | (1) |
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4.9.11 Nonconforming products and services |
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134 | (1) |
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4.9.12 Other considerations |
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134 | (1) |
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4.10 Documented information |
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135 | (4) |
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5 The structure of ISO 9001:2015 |
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139 | (100) |
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141 | (1) |
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142 | (1) |
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142 | (1) |
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4 Context of the organisation |
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143 | (5) |
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4.7 Understanding the organisation and its context |
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143 | (1) |
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4.2 Understanding the needs and expectations of interested parties |
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144 | (1) |
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4.3 Determining the scope of the Quality Management System |
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145 | (2) |
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4.4 Quality Management System and its processes |
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147 | (1) |
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148 | (8) |
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5.1 Leadership and commitment |
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149 | (3) |
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152 | (3) |
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5.3 Organisational roles, responsibilities and authorities |
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155 | (1) |
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156 | (7) |
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6.1 Actions to address risks and opportunities |
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157 | (3) |
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6.2 Quality objectives and planning to achieve them |
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160 | (2) |
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162 | (1) |
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163 | (16) |
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163 | (8) |
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171 | (1) |
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172 | (1) |
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173 | (1) |
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7.5 Documented information |
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173 | (6) |
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179 | (38) |
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8.1 Operational planning and control |
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179 | (2) |
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8.2 Requirements for products and services |
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181 | (4) |
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8.3 Design and development of products and services |
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185 | (13) |
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8.4 Control of externally provided processes, products and services |
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198 | (7) |
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8.5 Production and service provision |
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205 | (7) |
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8.6 Release of products and services |
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212 | (2) |
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8.7 Control of nonconforming outputs |
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214 | (3) |
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217 | (13) |
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9.7 Monitoring, measurement, analysis and evaluation |
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218 | (5) |
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223 | (3) |
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226 | (4) |
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230 | (9) |
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230 | (1) |
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10.2 Nonconformity and corrective action |
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231 | (5) |
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10.3 Continual improvement |
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236 | (3) |
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6 Example Quality Management System |
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239 | (340) |
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579 | (26) |
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7.1 How ISO 9000 can be used to check small businesses' Quality Management Systems |
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580 | (1) |
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580 | (11) |
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582 | (2) |
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7.2.2 Internal audit programme |
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584 | (7) |
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591 | (4) |
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7.3.1 Supplier evaluation |
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591 | (4) |
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7.4 The surveillance or quality audit visit |
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595 | (2) |
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7.4.1 Multiple evaluations and audits |
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596 | (1) |
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596 | (1) |
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7.4.3 Third-party evaluation |
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596 | (1) |
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7.4.4 Conformity assessment |
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596 | (1) |
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7.5 Self-assessment checklists |
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597 | (2) |
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7.5.1 Documentation required by an organisation to meet ISO 9001:2015 requirements |
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597 | (1) |
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7.5.2 ISO 9001:2015 requirements of management |
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597 | (1) |
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7.5.3 Example checklists of typical auditors' questions for ISO 9001:2015 compliance |
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598 | (1) |
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7.5.4 Example internal stage audit checklists |
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598 | (1) |
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7.6 Documentation requirements |
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599 | (6) |
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599 | (3) |
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7.6.2 Control of documents |
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602 | (2) |
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7.6.3 Software programs for document control |
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604 | (1) |
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8 What are the costs involved in an organisation obtaining registration to this standard? |
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605 | (16) |
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8.1 Can I just work `incompliance' with ISO 9001? |
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606 | (1) |
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8.2 So why should I bother about getting ISO 9001 certification? |
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606 | (1) |
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8.3 But what is the difference to being a certified, accredited and/or a registered ISO 9001:2015 organisation? |
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607 | (1) |
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8.4 But is it worth the cost and trouble to become ISO 9001:2015 certified? |
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607 | (1) |
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8.5 What are the benefits of ISO international standards? |
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608 | (1) |
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8.6 How do I become an ISO 9001 registered organisation? |
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609 | (2) |
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8.7 How long will it take to become certified? |
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611 | (1) |
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8.8 How is the certification completed? |
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612 | (1) |
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8.9 What happens during the actual ISO 9001 audit?! |
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612 | (1) |
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8.10 What other national certification bodies are there? |
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613 | (2) |
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8.11 What happens after certification and beyond? |
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615 | (1) |
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8.12 How can I maintain my certification? |
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615 | (1) |
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8.13 What are the advantages of maintaining my ISO 9001:2015 certification? |
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615 | (6) |
Abbreviations and acronyms |
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621 | (4) |
Reference standards for Quality Management Systems |
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625 | (2) |
Glossary of terms used In Quality Management standards |
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627 | (6) |
Books by the author |
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633 | (6) |
Index |
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639 | |